System and method for supporting on the use of an injection device

ABSTRACT

A system for supporting on the use of an injection device comprises a display and a processor configured to determine the injection device, to obtain data on use of the determined injection device and to add at least one overlay on the display, wherein the at least one overlay is generated depending on the obtained data on use of the determined injection device. The processor is configured to adapt the at least one overlay depending on a context of application of the injection device, the context of application of the injection device comprising at least one of the following: ambient light; time; date; temperature; use history of the injection device; drug; injection site; dosage.

FIELD

This relates to a system and method for supporting on the use of aninjection device.

BACKGROUND

Injection devices, such as auto-injectors, are known in the art fordispensing a medicament to the injection site of a patient. Injectionsby using injection devices can be applied either by medical personnel orby patients themselves. For application of an injection device, it maybe helpful especially for patients to obtain support on the use of aninjection device.

EP 3 200 109 A1 discloses a head-mounted display device for interfacewith a medical device configured to perform an invasive procedure on apatient, such as a blood component collection, an infusion, a feedingoperation, etc.

SUMMARY

A first aspect provides a system for supporting on the use of aninjection device comprising a display and a processor being configuredto determine the injection device, to obtain data on use of thedetermined injection device and to add at least one overlay on thedisplay, wherein the at least one overlay is generated depending on theobtained data on use of the determined injection device. The system mayfor instance be implemented by a mobile computing device, particularly ahandheld device, such as a smartphone or a tablet computer, or awearable device, such as an optical head-mounted display. However, alsoa computer coupled to a camera or having a built-in camera, for instancea webcam, can be used instead. A display may be a transparent display,on which the at least one overlay is projected or displayed, such asutilized in an optical head-mounted display, a non-transparent display,on which the at least one overlay is displayed together with arepresentation of an image of the injection device captured with animage component, such as utilized in a smartphone, a tablet computer, ahead-mounted display with active displays like LCD or OLED screens, or avirtual display such as the retina of a viewer's eye. The system may beused to implement an augmented reality support of patients and medicalpersonnel on using the injection device.

The at least one overlay may comprise textual information, a videoand/or one or more images. For instance, the textual information maycomprise hints on the use of the injection device, the video may be atraining video showing proper use of the injection device, and theimages may show different aspects of the use of the injection devices.

The processor may be configured to determine the injection device withimage processing of a captured image of the injection device, whereinthe image processing comprises detecting a form of, a colour of, a code,a tag and/or a label on the injector device, and determining theinjection device depending on of the detected form, colour, code, tag,label.

The processor may be configured to determine the injection device byreceiving injection device identification data. For instance, theinjection device identification data can be electronically stored in aninternal storage of the injection device. The internal storage may befor instance implemented by a RFID or NFC chip or tag. The system mayfor instance comprise a wireless receiver for receiving the injectiondevice identification data, wherein the wireless receiver particularlycomprises at least one of the following: a RFID reader; a NFC reader; aBluetooth® receiver.

The system may comprise an image capturing component to capture an imageof the injection device, wherein the processor is configured to displaythe captured image of the injection device on the display together withthe at least one overlay. For instance, a mobile computing device with abuilt-in camera such as a smartphone can be used to capture the imageand display it on its own screen together with the overlay(s).

The processor may be configured to adapt the at least one overlaydepending on environmental conditions, particularly depending on of thefollowing: ambient light, time, date, temperature. For instance, anoverlay may be displayed in different colours depending on time, dateand/or temperature, such as in red colour when it is too late for aninjection or the ambient temperature is outside a predeterminedtemperature range for injection.

The processor may be configured to generate the at least one overlay byloading the data on use of the determined injection device from aninternal storage and/or from an external storage by means of a dataconnection, particularly a wireless data connection. For instance, ifthe system is implemented by a mobile computing device having a dataconnection, the information can be downloaded from a webserver via asecure data connection. Alternatively, or additionally, some or all theinformation can also be stored in an internal storage of the system, forexample in a non-volatile memory of a mobile computing device.

The processor may be configured to detect user actions and to adapt theat least one overlay depending on detected user actions. User actionsmay comprise for instance user inputs via buttons, or gestures, or voicecommands. The user actions may be processed by the processor forinstance to control the representation of the at least one overlay, forexample by sequentially displaying various instructions and/or hints forthe use of the injection device depending on processed user actions.

The processor may be configured to store data regarding a use history ofthe injection device. Use history data may for instance comprise timeand date stamps of a usage of the injection device, injection site, andinjection dose.

Another aspect of the specification provides a method for supporting onthe use of an injection device comprising determining the injectiondevice, obtaining data on use of the determined injection device andadding at least one overlay on a display, wherein the at least oneoverlay is generated depending on the obtained data on use of thedetermined injection device.

Another aspect of the specification provides a device comprising aprocessor, a memory, a display, a camera, and a software stored in anon-volatile part of the memory, wherein the software configures theprocessor of the device to capture one or more images of an injectiondevice with the camera, to show a captured image of the injection deviceon the display, to determine the injection device, to obtain data on useof the determined injection device and to add at least one overlay onthe display, wherein the at least one overlay is generated depending onthe obtained data on use of the determined injection device.

The device may be for example a smartphone, a Personal DigitalAssistant, a tablet or laptop computer, or a head-mounted displaydevice.

The adapting of the at least one overlay depending on a context ofapplication of the injection device may comprise at least one of thefollowing: displaying the overlay in different colours depending on atleast one of the following: ambient light; time; date; temperature; usehistory of the injection device; drug; injection site; dosage; alteringthe displayed content of the overlay depending on at least one of thefollowing: ambient light; time; date; temperature; use history of theinjection device; drug; injection site; dosage; altering the size of theoverlay depending on at least one of the following: ambient light; time;date; temperature; use history of the injection device; drug; injectionsite; dosage; selecting the position of the overlay on the displaydepending on at least one of the following: ambient light; time; date;temperature; use history of the injection device; drug; injection site;dosage.

BRIEF DESCRIPTION OF THE FIGURES

In the Figures:

FIG. 1 shows a system according to embodiments;

FIG. 2 shows a schematic view of a device of the system according toembodiments; and FIG. 2 shows a flowchart of a method according toembodiments.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

The system and method described herein can be advantageously used fortraining and assisting of a patient or a user of an injection device,particularly an auto-injector device, via augmented reality. The systemand method utilizes an augmented reality application, for exampleembedded in a smartphone, to display one or more overlays on a display,such as a smartphone screen or lenses of an optical head-mounteddisplay, with overlay(s) being generated by a processor depending ondata on use of an injection device.

An overlay may comprise information such as training videos for theproper use of the injection device, a history of the usage of theinjection device, safety information for a user, step-by-step guidanceinformation for the proper use of the injection device, alerts, usagefeedback, and the like. Thus, the system and method may provide supporton the use of the injection device, particularly provide additionaltraining and safety for the user.

A system according to embodiments can be implemented by a display forrepresenting the overlay(s) and a processor configured to determine theinjection device, for which support is required, to obtain data on useof the determined injection device, and to generate one or more overlaysdepending on the obtained data and a context of application of theinjection device, which may comprise at least one of the following:ambient light; time; date; temperature; use history of the injectiondevice; drug; injection site; dosage.

A smartphone or a head-mounted display with a software implementing an“augmented reality” system according to embodiments can be used ashardware. The hardware can be also configured to determine the injectiondevice for which an augmented reality representation should begenerated. The determination can be implemented by making a scan of theinjection device or by receiving identification data of the injectiondevice.

After determination of the injection device, data on use of theinjection device can be loaded, for example a training videodemonstrating proper use of the injection device, an instruction manual,and/or a usage history of the injection device.

FIG. 1 shows an implementation of the inventive system by means of asmartphone 10 comprising an LCD, TFT (thin film transistor), OLED(organic light emitting diode) or ePaper screen as display 12 and anintegrated camera module as image capturing component 14. The smartphone10 is configured by a software such as an “app” downloaded to andinstalled on the smartphone to implement the inventive system.

FIG. 2 is a schematic view of the smartphone 10 of FIG. 1 showinginternal components of the smartphone 10. The smartphone 10 comprises amemory 102, i.e. a working or volatile memory, such as Random AccessMemory (RAM), and a non-volatile memory. The non-volatile memory storesan operating system and the software 104 for supporting on the use of aninjection device, which advantageously is a distinct application, aswell as storing data files and associated metadata. The software 104 maybe provided in the smartphone 10 on manufacture or it may be downloadedinto the smartphone 10, for instance from an application market place orapplication store, or it may be side loaded into the smartphone 10. Thedisplay 12 of the smartphone 10 may be a touch sensitive display havinga display part 106 and a tactile interface part 107. The smartphone 10also includes a communications interface 108, such as a Bluetooth, acellular radio and/or a WLAN (Wireless Local Area Network) interface.The smartphone 10 is further equipped with an ambient light sensor fordetecting the ambient light at the location of the smartphone 10.Furthermore, the smartphone 10 may be equipped with a temperature sensorfor measuring the ambient temperature, for example the room temperature.The smartphone 10 also houses a battery 105 to power the smartphone 10by a power supply 103. The camera 14 of the smartphone 10 may be of adigital type and may comprise an imaging sensor for digitally capturingimages, which can be stored in the RAM or the non-volatile memory. Aprocessor 101 of the smartphone 10 is configured to send and receivesignals to and from the other components in order to control operationof the other components. For example, the processor 101 controls thedisplay of content on display 106 and receives signals as a result ofuser inputs from tactile interface 107. The display 106 may be aresistive touch screen or capacitive touch screen of any kind. Thedisplay may alternatively not be a touch screen. For instance, it may bea liquid crystal display (LCD).

The software 104 configures the processor 101 of the smartphone 10 tocapture images of an injection device 16 with the camera module 14 andto display the captured images on the display 12 of the smartphone 10 sothat the real injection device 16 is displayed on the display 12.

Thereafter, the software configures the processor to determine theinjection device 16, i.e. the kind and type of injection device, byidentifying the injection device 16. Various options for identifying theinjection device 16 may be implemented depending on available hardwareresources of the smartphone:

1. The software may comprise image processing capability, with which acaptured image showing the injection device 16 may be processed and inthe course of the processing characteristic features of the injectiondevice may be detected such as the form of the entire injection device16 or the form of parts of the device 16, particularly of the device'shousing 160, the form, particularly the length of a needle 161, theform, particularly the dimensions of a drug container 162, and/or thecolour of the entire device 16 or of parts 160, 161, 162 of the device16, and/or a code 163, a tag such as a QR-tag, a label printed on thehousing 160 or another part such the drug container 162. The code 163,the tag, the label may be detected by OCR (Optical CharacterRecognition) technology.2. The software may upload a captured image showing the injection device16 via a data connection to an image processing service provider such asa web service or an image processing program executed by a computer,which is connected to the smartphone 10. Thus, the software and thesmartphone itself do not need to provide image processing capabilities,which sometimes require computing resources beyond the capabilities ofsmartphones.3. If the smartphone 10 is equipped with a wireless receiver, forexample a Bluetooth® receiver, a NFC (Near Field Communication) readerand/or a RFID (Radio Frequency Identification) reader, and the injectiondevice 16 comprises a Bluetooth® transmitter, a NFC tag and/or a RFIDtag, the processor of the smartphone 10 can obtain injection deviceidentification data via a wireless data connection 164 between thesmartphone 10 and the injection device 16. The identification data maybe stored in an internal memory of the injection device 16 and/or theNFC tag and/or RFID tag. The identification data can also be transmittedvia a IR (infrared) or an optical data connection, or by means of awired data connection for instance comprising an USB (Universal SerialBus) data connection.

When the injection device 16 is identified by one of the aboveprocesses, the software proceeds with obtaining data on the use of theidentified injection device 16 (use support data). The use support datacan be part of the application or streamed/downloaded from servers,which requires a high-speed internet connection, and may comprisetraining information on use of the identified injection device such asvideo, textual, audio, image information, for instance training videos(user steps/step by step training), device usage history or safetyinformation for a user. The use support data may also compriseinformation on accessories shown in a captured image of the injectiondevice.

The use support data may be received from various sources as listed inthe following:

-   -   1. The use support data may be stored in an internal storage of        the smartphone, for instance can be part of the software, and,        thus can loaded by the processor in the smartphone's main memory        for further processing.    -   2. The use support data may also be stored in an external        storage such as a server, a webserver or the like. In such case,        the software may configure the processor of the smartphone to        contact the external storage via a data connection, for example        a wireless data connection, and to download and/or stream the        required use support data into the main memory of the smartphone        for further processing.    -   3. The use support data may also be obtained from an internal        storage of the injection device such as non-volatile memory of        an electronic integrated in the injection device. For instance,        the injection device may be equipped with an electronic        comprising a controller, a wireless transceiver, and a        non-volatile memory. The use support data may be stored in the        non-volatile memory. The software executed by the processor of        the smartphone may configure the processor to establish a        wireless data connection with the wireless transceiver of the        injection device's integrated electronic depending on the        identified injection device. Upon establishment of the wireless        data connection, the software may request the stored use support        data and receive the requested data via the established wireless        data connection.

After obtaining the use support data for the identified injection device16, the software proceeds with configuring the processor to generate oneor more overlays on the display 12. The overlays may be generated suchthat they may give a user of the injection device 16 support on its use,particularly by means of boxes 120, 121 containing textual informationon the use of certain parts of the injection device 16 and a textualinformation 122 with the injection device's 16 identification code. Thetextual information boxes 120, 121 may be displayed near, at or over therespective parts of the captured image of the injection device on thedisplay 12 so that a user can immediately get hints on using theinjection device by seeing the textual information boxes 120, 121. Butalso, a video and/or image(s) may be displayed by one or more overlays.The video and/or image may be for instance displayed in a transparentmode such that it overlays the captured image of the injection device onthe display 12 and may demonstrate a proper use of the injection device.

The generation of the one or more overlays on the display 12 comprisesan adaptation of the overlays depending on a context of application ofthe injection device 16 in order to better assist a user or patient inusing the injection device.

The adaptation of the overlays may comprise displaying an overlay indifferent colours, altering the displayed content of the overlay,altering the size of the overlay, selecting the position of the overlay.The context of application of the injection device 16 may comprise oneor more environmental conditions such as ambient light, temperature,time and/or date, and one or more injection related conditions such asuse history of the injection device, drug, injection site, dosage.Examples of an adaptation of an overlay depending on the context of anapplication of the injection device are listed in the following:

-   -   when the ambient light is below a certain threshold the colour        and/or size of an overlay may be altered in order to make it        easier for a patient to recognize the overlay even under bad        lighting conditions;    -   when the temperature is outside a recommended or required range        for the injection, the content of an overlay may be altered to        display a warning message, and/or the colour of an overlay may        be changed to a colour such as red or yellow to warn a patient        of non-suitable environmental condition for an injection, and/or        the size of an overlay may be increased such that a patient        cannot overlook it;    -   when the time and/or date differs from a prescribed medication        plan, the content, colour, size and/or position of an overlay        may be altered such that a patient can easily recognize the        overlay and note that an injection is actually not required and        prescribed;    -   when the use history of the injection device shows that actually        an injection is (not) necessary and/or (not) prescribed, the        content, colour, size and/or position of an overlay may be        altered such that a patient can easily recognize the overlay and        note that an injection is actually (not) required and        prescribed, and can also see when the last injection has        occurred;    -   the drug can be displayed by a respectively adapted overlay, for        example be changing size, position, colour, and/or content of        the overlay informing a patient of the kind of drug and the drug        itself, such as altering a patient of an important insulin        injection with a big red overlay positioned in the middle of a        display with a content emphasizing the importance;    -   an injection site can be shown by an overlay with a highlighting        colour and a position on the display, where the injection site        is shown so that a patient is assisted in making the injection;    -   a dosage to be injected can be shown by selecting an overlay        representing the required dosage, for example by showing an icon        representing the dosage in a colour and/or size which allow a        patient to easily recognize the required dosage.

FIG. 2 shows a flowchart of the software executed by the processor ofthe smartphone. After launching the software on the smartphone (stepSTART), the software initiates in step 200 the built-in smartphonecamera 14 to captures images of the injection device 16 in a subsequentstep 202. The captured images are displayed on the smartphone screen instep 204, thus, showing a real representation of the injection device,i.e. the “reality”. In step 206, the software checks whetheridentification data were received from the injection device 16, eitherwirelessly or wired. If identification data were received, the softwarecontinues in step 208 with loading textual information, video(s) and/orimage(s) on use of the injection device 16 by using the receivedidentification data from one or more of the sources as explained before.If no identification data were received, the software proceeds with step212 instead of step 208 and initiates an image processing of a capturedimage of the injection device 16 for detecting form, colour of and/or acode on the injection device. In step 214, the software checks whether acode was detected by the image processing, and if so proceeds with step216, in which textual information, video(s) and/or image(s) on use ofthe injection device 16 are loaded by using the detected code from oneor more of the sources as explained before. If no code was detected bythe image processing, the software retrieves the injection device withthe detected form and/or colour in step 218, and loads textualinformation, video(s) and/or image(s) on use of the retrieved injectiondevice 16 in the following step 220. In step 222 following steps 208,216, and 220, the software then generates one or more overlayscontaining the loaded information and adds them in subsequent step ss4on the smartphone display or screen to overlay the representation of the“real” injection device 16 to create an augmented reality for the user.In step 226, the software checks whether a termination command wasreceived, and if so stops to execute. Until no termination command isdetected in step 226, the software cycles through steps 222 and 224 togenerate and add overlay(s) on the smartphone screen, wherein thecontent of the overlay may vary through each cycle, for instance maydisplay a step by step guidance for the user.

In the following, some further possible applications and implementationof the embodiments are briefly described:

The augmented reality created by the software can be also used to auditand document the use of the injection device 16. A step by step trainingmay for instance visualize the user steps. There may be a subsequentcontrol (via (photo—) camera) for the performed user steps, which meansthe user imitates the shown visualizations and the software controls theuser actions and gives feedback. In case of a correct user step thetraining continues showing the next step, in case of a wrong user stepit gives an alert for instance and the training is not continued untilthe user is able to perform the respective step correctly. The users getthe confirmation that they are using the device correctly. The softwaremay also give alerts if errors or misuse is detected and proposessolutions. The feedback can be visible (text, image or light), audible(sound) or haptic (vibration alert). This shall enhance confidence aswell as user understanding.

The smartphone 10 can be put down while using the application withoutinterruption (pauses can be recognized e.g. for performing a two-handedstep). Thereby the user can skip information or there may be a procedurewhich detects the condition of the injection device 16 by means ofsignificant changed geometries on the injector device (e.g. cap attachedvs. not attached).

The user can document the injection site, time and dose manually in thesoftware or it can be documented when the camera 14 films it. Theapplication could also give notifications like alerts at defined timeswhen the user should inject the drug. It could also validate if thecorrect drug is used depending on user information. Alerts can beprogrammed as reminders e.g. when the injection device should be takenout of the refrigerator or when to inject after a defined acclimatizingtemperature has been reached. An electronic, for instance a RFID chipintegrated into the injection device 16 could additionally report statusof the injection and confirm successful injection; the information coulddirectly be logged in an injection track record.

The terms “drug” or “medicament” are used synonymously herein anddescribe a pharmaceutical formulation containing one or more activepharmaceutical ingredients or pharmaceutically acceptable salts orsolvates thereof, and optionally a pharmaceutically acceptable carrier.An active pharmaceutical ingredient (“API”), in the broadest terms, is achemical structure that has a biological effect on humans or animals. Inpharmacology, a drug or medicament is used in the treatment, cure,prevention, or diagnosis of disease or used to otherwise enhancephysical or mental well-being. A drug or medicament may be used for alimited duration, or on a regular basis for chronic disorders.

As described below, a drug or medicament can include at least one API,or combinations thereof, in various types of formulations, for thetreatment of one or more diseases. Examples of API may include smallmolecules having a molecular weight of 500 Da or less; polypeptides,peptides and proteins (e.g., hormones, growth factors, antibodies,antibody fragments, and enzymes); carbohydrates and polysaccharides; andnucleic acids, double or single stranded DNA (including naked and cDNA),RNA, antisense nucleic acids such as antisense DNA and RNA, smallinterfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleicacids may be incorporated into molecular delivery systems such asvectors, plasmids, or liposomes. Mixtures of one or more drugs are alsocontemplated.

The drug or medicament may be contained in a primary package or “drugcontainer” adapted for use with a drug delivery device. The drugcontainer may be, e.g., a cartridge, syringe, reservoir, or other solidor flexible vessel configured to provide a suitable chamber for storage(e.g., short- or long-term storage) of one or more drugs. For example,in some instances, the chamber may be designed to store a drug for atleast one day (e.g., 1 to at least 30 days). In some instances, thechamber may be designed to store a drug for about 1 month to about 2years. Storage may occur at room temperature (e.g., about 20° C.), orrefrigerated temperatures (e.g., from about −4° C. to about 4° C.). Insome instances, the drug container may be or may include a dual-chambercartridge configured to store two or more components of thepharmaceutical formulation to-be-administered (e.g., an API and adiluent, or two different drugs) separately, one in each chamber. Insuch instances, the two chambers of the dual-chamber cartridge may beconfigured to allow mixing between the two or more components prior toand/or during dispensing into the human or animal body. For example, thetwo chambers may be configured such that they are in fluid communicationwith each other (e.g., by way of a conduit between the two chambers) andallow mixing of the two components when desired by a user prior todispensing. Alternatively or in addition, the two chambers may beconfigured to allow mixing as the components are being dispensed intothe human or animal body.

The drugs or medicaments contained in the drug delivery devices asdescribed herein can be used for the treatment and/or prophylaxis ofmany different types of medical disorders. Examples of disordersinclude, e.g., diabetes mellitus or complications associated withdiabetes mellitus such as diabetic retinopathy, thromboembolismdisorders such as deep vein or pulmonary thromboembolism. Furtherexamples of disorders are acute coronary syndrome (ACS), angina,myocardial infarction, cancer, macular degeneration, inflammation, hayfever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs anddrugs are those as described in handbooks such as Rote Liste 2014, forexample, without limitation, main groups 12 (anti-diabetic drugs) or 86(oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type 1 or type2 diabetes mellitus or complications associated with type 1 or type 2diabetes mellitus include an insulin, e.g., human insulin, or a humaninsulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1analogues or GLP-1 receptor agonists, or an analogue or derivativethereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or apharmaceutically acceptable salt or solvate thereof, or any mixturethereof. As used herein, the terms “analogue” and “derivative” refers toa polypeptide which has a molecular structure which formally can bederived from the structure of a naturally occurring peptide, for examplethat of human insulin, by deleting and/or exchanging at least one aminoacid residue occurring in the naturally occurring peptide and/or byadding at least one amino acid residue. The added and/or exchanged aminoacid residue can either be codable amino acid residues or othernaturally occurring residues or purely synthetic amino acid residues.Insulin analogues are also referred to as “insulin receptor ligands”. Inparticular, the term “derivative” refers to a polypeptide which has amolecular structure which formally can be derived from the structure ofa naturally occurring peptide, for example that of human insulin, inwhich one or more organic substituent (e.g. a fatty acid) is bound toone or more of the amino acids. Optionally, one or more amino acidsoccurring in the naturally occurring peptide may have been deletedand/or replaced by other amino acids, including non-codeable aminoacids, or amino acids, including non-codeable, have been added to thenaturally occurring peptide. Examples of insulin analogues are Gly(A21),Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29)human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin(insulin lispro); Asp(B28) human insulin (insulin aspart); humaninsulin, wherein proline in position B28 is replaced by Asp, Lys, Leu,Val or Ala and wherein in position B29 Lys may be replaced by Pro;Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) humaninsulin and Des(B30) human insulin.

Examples of insulin derivatives are, for example,B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®);B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin;B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 humaninsulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) humaninsulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30)human insulin (insulin degludec, Tresiba®);B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, forexample, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®,Bydureon®, a 39 amino acid peptide which is produced by the salivaryglands of the Gila monster), Liraglutide (Victoza®), Semaglutide,Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®),rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide/HM-11260C, CM-3,GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen,Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701,MAR709, ZP-2929, ZP-3022, TT-401, BHM-034. MOD-6030, CAM-2036, DA-15864,ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten. An examples of anoligonucleotide is, for example: mipomersen sodium (Kynamro®), acholesterol-reducing antisense therapeutic for the treatment of familialhypercholesterolemia.

Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin,Saxagliptin, Berberine.

Examples of hormones include hypophysis hormones or hypothalamushormones or regulatory active peptides and their antagonists, such asGonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin),Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronicacid, a heparin, a low molecular weight heparin or an ultra-lowmolecular weight heparin or a derivative thereof, or a sulphatedpolysaccharide, e.g. a poly-sulphated form of the above-mentionedpolysaccharides, and/or a pharmaceutically acceptable salt thereof. Anexample of a pharmaceutically acceptable salt of a poly-sulphated lowmolecular weight heparin is enoxaparin sodium. An example of ahyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodiumhyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulinmolecule or an antigen-binding portion thereof. Examples ofantigen-binding portions of immunoglobulin molecules include F(ab) andF(ab′)2 fragments, which retain the ability to bind antigen. Theantibody can be polyclonal, monoclonal, recombinant, chimeric,de-immunized or humanized, fully human, non-human, (e.g., murine), orsingle chain antibody. In some embodiments, the antibody has effectorfunction and can fix complement. In some embodiments, the antibody hasreduced or no ability to bind an Fc receptor. For example, the antibodycan be an isotype or subtype, an antibody fragment or mutant, which doesnot support binding to an Fc receptor, e.g., it has a mutagenized ordeleted Fc receptor binding region. The term antibody also includes anantigen-binding molecule based on tetravalent bispecific tandemimmunoglobulins (TBTI) and/or a dual variable region antibody-likebinding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptidederived from an antibody polypeptide molecule (e.g., an antibody heavyand/or light chain polypeptide) that does not comprise a full-lengthantibody polypeptide, but that still comprises at least a portion of afull-length antibody polypeptide that is capable of binding to anantigen. Antibody fragments can comprise a cleaved portion of a fulllength antibody polypeptide, although the term is not limited to suchcleaved fragments. Antibody fragments that are useful in the presentinvention include, for example, Fab fragments, F(ab′)2 fragments, scFv(single-chain Fv) fragments, linear antibodies, monospecific ormultispecific antibody fragments such as bispecific, trispecific,tetraspecific and multispecific antibodies (e.g., diabodies, triabodies,tetrabodies), monovalent or multivalent antibody fragments such asbivalent, trivalent, tetravalent and multivalent antibodies, minibodies,chelating recombinant antibodies, tribodies or bibodies, intrabodies,nanobodies, small modular immunopharmaceuticals (SMIP), binding-domainimmunoglobulin fusion proteins, camelized antibodies, and VHH containingantibodies. Additional examples of antigen-binding antibody fragmentsare known in the art.

The terms “Complementarity-determining region” or “CDR” refer to shortpolypeptide sequences within the variable region of both heavy and lightchain polypeptides that are primarily responsible for mediating specificantigen recognition. The term “framework region” refers to amino acidsequences within the variable region of both heavy and light chainpolypeptides that are not CDR sequences, and are primarily responsiblefor maintaining correct positioning of the CDR sequences to permitantigen binding. Although the framework regions themselves typically donot directly participate in antigen binding, as is known in the art,certain residues within the framework regions of certain antibodies candirectly participate in antigen binding or can affect the ability of oneor more amino acids in CDRs to interact with antigen.

Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

Pharmaceutically acceptable salts of any API described herein are alsocontemplated for use in a drug or medicament in a drug delivery device.Pharmaceutically acceptable salts are for example acid addition saltsand basic salts.

Those of skill in the art will understand that modifications (additionsand/or removals) of various components of the APIs, formulations,apparatuses, methods, systems and embodiments described herein may bemade without departing from the full scope and spirit of the presentdisclosure, which encompass such modifications and any and allequivalents thereof.

1. A system for supporting on the use of an injection device comprisinga display and a processor being configured to determine the injectiondevice, to obtain data on use of the determined injection device and toadd at least one overlay on the display, wherein the at least oneoverlay is generated depending on the obtained data on use of thedetermined injection device, and wherein the processor is configured toadapt the at least one overlay depending on a context of application ofthe injection device, the context of application of the injection devicecomprising at least one of the following: ambient light; time; date;temperature; use history of the injection device; drug; injection site;dosage.
 2. A system of claim 1, wherein the at least one overlaycomprises textual information, a video and/or one or more images.
 3. Asystem of claim 1 or 2, wherein the processor is configured to determinethe injection device with image processing of a captured image of theinjection device, wherein the image processing comprises detecting aform of, a colour of, a code, a tag and/or a label on the injectordevice, and determining the injection device depending on of thedetected form, colour, code, tag, label.
 4. A system of claim 1, 2 or 3,wherein the processor is configured to determine the injection device byreceiving injection device identification data.
 5. A system of any ofthe preceding claims, comprising an image capturing component to capturean image of the injection device, wherein the processor is configured todisplay the captured image of the injection device on the displaytogether with the at least one overlay.
 6. A system of any of thepreceding claims, wherein the processor is configured to generate the atleast one overlay by loading the data on use of the determined injectiondevice from an internal storage and/or from an external storage by meansof a data connection, particularly a wireless data connection.
 7. Asystem of any of the preceding claims, wherein the processor isconfigured to detect a user action and to adapt the overlay depending onthe detected user action.
 8. A system of any of the preceding claims,wherein the processor is configured to store data regarding a usehistory of the injection device.
 9. A method for supporting on the useof an injection device comprising determining the injection device,obtaining data on use of the determined injection device and adding atleast one overlay on a display, wherein the at least one overlay isgenerated depending on the obtained data on use of the determinedinjection device and adapted depending on a context of application ofthe injection device, the context of application of the injection devicecomprising at least one of the following: ambient light; time; date;temperature; use history of the injection device; drug; injection site;dosage.
 10. A device comprising a processor, a memory, a display, acamera, and a software stored in a non-volatile part of the memory,wherein the software configures the processor of the device to captureone or more images of an injection device with the camera, to show acaptured image of the injection device on the display, to determine theinjection device, to obtain data on use of the determined injectiondevice and to add at least one overlay on the display, wherein the atleast one overlay is generated depending on the obtained data on use ofthe determined injection device and adapted depending on a context ofapplication of the injection device, the context of application of theinjection device comprising at least one of the following: ambientlight; time; date; temperature; use history of the injection device;drug; injection site; dosage.
 11. A device of claim 11, being asmartphone, a Personal Digital Assistant, a tablet or laptop computer,or a head-mounted display device.
 12. A system of any of claims 1 to 8,a method of claim 9 or a device of claim 10 or 11, wherein the adaptingof the at least one overlay depending on a context of application of theinjection device comprises at least one of the following: displaying theoverlay in different colours depending on at least one of the following:ambient light; time; date; temperature; use history of the injectiondevice; drug; injection site; dosage; altering the displayed content ofthe overlay depending on at least one of the following: ambient light;time; date; temperature; use history of the injection device; drug;injection site; dosage; altering the size of the overlay depending on atleast one of the following: ambient light; time; date; temperature; usehistory of the injection device; drug; injection site; dosage; selectingthe position of the overlay on the display depending on at least one ofthe following: ambient light; time; date; temperature; use history ofthe injection device; drug; injection site; dosage.